B40 Users Guide Rev H

B40 Patient Monitor User's Guide Related to software VSP-B 0459 All specifications are subject to change without notice. Document no. 2062462-002 H 11 November 2015

GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee, WI USA Zip: 53223 Tel: +1 414 355 5000 (outside US) 800 558 5102 (US only) Fax: +1 414 355 3790 www.gehealthcare.com

Copyright © 2015 General Electric Company. All rights reserved.

GE Healthcare 3F Building 1, GE Technology Park 1 Huatuo Road Shanghai PRC 201203 Tel: +86 21 3877 7888 Fax: +86 21 3877 7451

Contents Safety precautions... 1

Impedance respiration...73

About this device... 3

Pulse oximetry (SpO2)...77

About this manual... 6

Non-invasive blood pressure (NIBP)...83

System introduction... 9

Invasive blood pressure...89

Symbols...15

Temperature...93

Monitoring basics...18

Airway gas...95

Setting up the monitor before use...25

Entropy... 105

Alarms...33

Troubleshooting... 111

Starting and ending...41

Messages... 114

Trends and OCRG...45

Abbreviations... 119

Printing and recording...49

Technical specifications... 125

Cleaning and care...53

Electromagnetic Compatibility... 139

ECG...61

Warranty... 145

Pacemaker detection...67 Arrhythmia detection...69 ST Detection...71

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Safety precautions These precautions refer to the entire system. Warnings and cautions specific to parts of the system can be found in the relevant section. •

Safety message signal words Safety message signal words designate the severity of a potential hazard. Danger Indicates a hazardous situation that, if not avoided, will result in death or serious injury. Warning Indicates a hazardous situation that, if not avoided, could result in death or serious injury. Caution Indicates a hazardous situation that, if not avoided, could result in minor or moderate injury. Notice Indicates a hazardous situation not related to personal injury that, if not avoided, could result in property damage.

•

Danger safety messages

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• • • • •

No danger safety messages apply to this monitoring system. •

Warning safety messages The following warning safety messages apply to this monitoring system. • Read all the safety information before using the monitor for the first time. • Equipment is intended for clinical professionals. • For continued safe use of this equipment, it is necessary that the listed instructions are followed. However, instructions listed in this manual in no way supersede established medical practices concerning patient care. • Single-use devices and accessories are not designed to be reused. Reuse may cause a risk of contamination and affect the measurement accuracy.

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There are hazards associated with the reuse of single-use sample tubing and adapters Inspect the sensor for signs of physical damage. Discard a damaged sensor immediately. Never repair a damaged sensor; never use a sensor repaired by others. Do not sterilize or immerse the sensor or cable in liquid. Do not spray or soak the connectors. Do not route cables in a way that presents tripping hazard Route all cables away from patient’s throat to avoid possible strangulation. Do not touch the patient, table, instruments, modules or the monitor during defibrillation. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. Always check that power cord and plug are intact and undamaged. Use only approved accessories, including mounts, and defibrillator-proof cables and invasive pressure transducers. For a list of approved accessories, see the supplies and accessories list delivered with the monitor. Other cables, transducers and accessories may cause a safety hazard, damage the equipment or system, result in increased emissions or decreased immunity of the equipment or system or interfere with the measurement. DISCONNECTION FROM MAINS - When disconnecting the system from the power line, remove the plug from the wall outlet first. Then you may disconnect the power cord from the device. If you do not observe this sequence, there is a risk of coming into contact with line voltage by inserting metal objects, such as the pins of leadwires, into the sockets of the power cord by mistake.

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If liquid has accidentally entered the system or its parts, disconnect the power cord from the power supply and have the equipment serviced by authorized service personnel. If service message appears, discontinue use as soon as possible and have the device repaired. PROTECTED LEADWIRES - Only use protected leadwires and patient cables with this monitor When applying devices intracardially, never contact electrically conductive parts connected to the heart (pressure transducers, metal tube connections and stopcocks, guide wires, etc.). Do not use the monitor in high electromagnetic fields (for example, during MRI). Do not tilt the monitor to avoid liquid entering. Do not touch the electrical connector located within the extension rack housing. Never store the monitor with the batteries inside. Storing the monitor with the batteries inside may result in damage to the monitor. NETWORK INTEGRITY - The monitor resides on the CARESCAPE, S/5 and/or HL7 network. It is possible that inadvertent or malicious network activity could adversely affect patient monitoring. The integrity of the network is the responsibility of the hospital.

Caution safety messages The following caution safety messages apply to this monitoring system. • U.S. Federal law restricts this device to sale by or on the order of a physician. • SUPERVISED USE - This equipment is intended for use under the direct supervision of a licensed health care practitioner. • Dispose of equipment in compliance with instructions and regulations

• • • • •

DATA LOSS - No Communication may occur at central station due to RF interference Reset the monitor if loss of monitoring data occurs. Leave space for circulation of air to prevent the monitor from overheating. Before connecting power, check voltage and frequency ratings of equipment. System time changes will result in time differences between stored and realtime data.

Notice safety message The following notice safety messages apply to this monitoring system. • NOTICE - The warranty does not cover damages resulting from the use of accessories and consumables from other manufacturers. • If the device has been transported or stored outside operating temperature allow it to stabilize back to operating temperature range before applying power. • The equipment is suitable for use in the presence of electrosurgery. Please notice the possible limitations in the parameter sections and in the “Techncial specification“ section.

About this device Indications for use

Service

This device is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.

If the product malfunctions or if assistance, service, or spare parts are required, contact GE service for technical support or contact your local representative. It is helpful for you to duplicate the problem, check and confirm the operation of all accessories to ensure that they are not the cause of the problem.

The B40 Patient Monitor is intended for use under the direct supervision of a licensed health care practitioner. The B40 Patient Monitor is not intended for use during MRI.

CE marking information

The B40 Patient Monitor can be a stand-alone monitor or interfaced to other devices via a network.

CE compliance The B40 Monitor bears CE Mark CE-0459 indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfills the essential requirements of Annex I of this directive. The country of manufacture can be found on the equipment labeling.

The B40 Patient Monitor monitors and displays : ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/ pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring( including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/ Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/ Room /Myocardial/ Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O and anesthetic agents), and Entropy.

The product complies with the requirements of standard IEC 606011-2 “Medical Electrical Equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility Requirements and tests”. The product meets Class A EMC limits in accordance with CISPR 11.

Training requirements No product-specific training is required for the use of this monitor.

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Classifications In accordance with IEC 60601-1: − Class I and internally powered equipment - the type of protection − − − −

against electric shock. Type BF or CF equipment. The degree of protection against electric shock is indicated by a symbol on each parameter module. Equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. Continuous operation according to the mode of operation. Portable Monitor

In accordance with IEC 60529: − IP21 - degree of protection against harmful ingress of water. In accordance with EU Medical Device Directive: − IIb In accordance with CISPR 11: − Group 1 Class A; •

•

Group 1 contains all ISM (Industrial, scientific and medical) equipment in which there is intentionally generated and/or used conductively coupled radio-frequency energy which is necessary for the internal functioning of the equipment itself. Class A equipment is equipment suitable for use in all establishments other than domestic and those directly connected to a low-voltage power supply network which supplies buildings used for domestic purposes.

In accordance with Underwriter’s Laboratory:

C 3ZG9

Medical Equipment With respect to electrical shock, fire and US mechanical hazards only in accordance with IEC 60601-1, UL 60601-1; IEC 60601-2-26; IEC 606012-27; IEC 60601-2-30; IEC 60601-2-34; IEC 606012-49; CAN/CSA C22.2 No. 601.1

Quality management system The quality management system complies with the international standards ISO 9001 and ISO 13485.

Responsibility of the manufacturer GE Medical Systems Information Technologies, Inc. is responsible for the safety, reliability and performance of the equipment only if:

− Assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by GE.

− The electrical installation of the relevant room complies with the requirements of the appropriate regulations.

− The equipment is used in accordance with the instructions for use.

− The equipment is installed, maintained and serviced in

accordance with the instructions provided in the related technical manuals.

Product availability Some of the products mentioned in this manual may not be available in all countries. Please consult your local representative for the availability.

Product Compliance Exception

The B40 Monitor is classified in the following categories for compliance: • • • • • • • • • • • • • • •

The TEMP parameter conforms to EN 12470-4 with the exception of Sub-clause 6.3 b)

This equipment is suitable for connection to public mains as defined in CISPR 11. This Monitor conforms to general safety standard for medical devices to IEC 60601-1. This Monitor conforms to EMC safety standard to IEC 60601-1-2. This Monitor conforms to usability safety standard for medical devices to IEC 60601-1-6. Software is developed in accordance with IEC 60601-1-4. The application of risk management analysis to medical device conforms to ISO 14971. The SpO2 Parameter conforms to ISO 9919. The TEMP parameter conforms to EN 12470-4. The CO2 parameter conforms to ISO 21647. This Monitor conforms to particular safety standard for multifunction patient monitoring equipment to IEC 60601-2-49 The invasive blood pressure parameter conforms to the IEC 60601-2-34 The ECG parameter conforms to ANSI/AAMI EC13, IEC 60601-227 with the exception of Sub-clause 50.102.8 a) The NIBP parameter conforms to IEC 60601-2-30, EN 1060-1, EN 1060-3, ANSI/AAMI SP10 The Entropy parameter conforms to IEC 60601-2-26. The alarm systems of the Monitor conform to IEC 60601-1-8.

NOTE: − EN 12470-4 Sub-clause 6.3 b): The accuracy of temperature probe : ± 0.1°C. − Exception: The accuracy of following B40 disposable temperature probe is ± 0.2°C and exceed the standard requirement ± 0.1°C • M1024222/2056776-001: Skin temperature probe (25/Box) • M1024231/2056777-001: General purpose temperature probe, 12F, (25/Box) • M1024229/2056778-001: General purpose temperature probe, 9F, (25/Box)

WARNING: B40 monitor use two kinds of temperature probes: disposable and reusable probes. The disposable probes’ accuracy exceed the requirement. The reusable probes are recommended to use according to clinical needs.

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About this manual This manual contains instructions necessary to operate this device in accordance with its functions and intended use. Descriptions refer to the software VSP-B Information which refers only to certain versions of the product is accompanied by the model number(s) of the product(s) concerned. The model number is given on the nameplate of the product.

Printed copies of this manual A paper copy of this manual will be provided upon request. Contact your local GE representative and request the part number on the first page of the manual.

Related documents

All illustrations in this manual are provided as examples only. They may not necessarily reflect your monitoring setup or data displayed on your monitor.

All publications conform with the product specifications and applicable IEC publications on safety and essential performance of electromedical equipment as well as with applicable UL and CSA requirements valid at the time of printing.

Conventions used in this manual

− Clinical aspects, basic methods of measurement and technical

Within this manual, special styles and formats are used to distinguish between terms viewed on screen, a button you must press, or a list of menu commands you must select:

− Installation, technical solutions and servicing: B40 Patient

− Names of hardware keys on the keypad are written in bold typeface: NIBP Start/Cancel. − Menu items are written in bold italic typeface: Monitor Setup. − Emphasized text is in italic typeface. − When referring to different sections in this manual, section

names are enclosed in double quotes: “Cleaning and care”. − The word “select” means choosing and confirming. − Messages (alarm messages, informative messages) displayed on the screen are written inside single quotes: 'Learning.' − Note statements provide application tips or other useful information.

background: B40 Patient Monitor User’s Reference Manual Monitor Technical Reference Manual

− Options and selections of the software: B40 Patient Monitor Default Configuration Worksheet

− Compatible supplies and accessories: B40 Patient Monitor Supplies and Accessories

− Other devices closely related to the monitor: • •

iCentral and iCentral Client User's Reference Manual CIC Pro Clinical Information Center Operator's Manual

Trademarks Listed below are GE Medical Systems Information Technologies and GE Healthcare Finland Oy trademarks used in this document. All other product and company names contained herein are the property of their respective owners. Datex, Ohmeda, DINAMAP, Trim Knob, Unity Network, CARESCAPE, EK-Pro, TruSignal, Entropy, GE Healthcare, GE Medical system, General Electric Company.

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System introduction Safety precautions

System components

Warnings

NOTE: Your system may not include all these components. Consult your local representative for the available components.

• • •

• •

All system devices must be connected to the same power supply circuit EXCESSIVE LEAKAGE CURRENT - Do not use a multiple socket outlet or extension cord. INTERFACING OTHER EQUIPMENT - Devices may only be interconnected with each other or to parts of the system when it has been determined by qualified biomedical personnel that there is no danger to the patient, the operator, or the environment as a result. In those instances where there is any element of doubt concerning the safety of the connected devices, the user must contact the manufacturers concerned (or other informed experts) for proper use. In all cases, safe and proper operation should be verified with the applicable manufacturer’s instructions for use, and system standards IEC 60601-1-1/EN 60601-1-1 must be complied with. The medical electrical equipment or medical electrical system may be interfered with by other equipment, even if that other equipment complies with CISPR EMISSION requirements. BEFORE INSTALLATION - Compatibility is critical to safe and effective use of this device. Please contact your local sales or service representative prior to installation to verify equipment compatibility.

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1, 4

1. 2. 3. 4.

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B40 monitor frame E modules: The compatible acquisition modules Extension rack Software: VSP-B

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Frame front view

Frame back view 2 1

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9 5 8

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1. Transportation handle 2. Alarm light 3. The Trim knob 4. Command board keys 5. Battery compartment 6. Guide rail for GCX mounting 7. Mains power and battery LEDs 8. On/Off key 9. Hemo connectors 10. E module 11. Recorder module

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1. 2. 3. 4. 5. 6. 7.

Receptacle for power cord Serial port Defibrillator connector Nurse call connector Network connector Equipotential connector Multi I/O connector

NOTE: 2,3,4 is on the multi I/O adpter.

E-miniC module

E-sCO, E-sCAiO module

2 2

1

1 3

3

4

1. Water trap 2. Sample gas inlet 3. Gas outlet

1. 2. 3. 4.

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E-sCAiO module

D-fend Pro water trap Gas sample, sampling line connector on the water trap Water trap container Gas exhaust, connector for the gas exhaust line (sampling gas out

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E-Entropy module

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2

1. Module keys 2. Entropy connector

How to identify the Hemo connectors’ configuration B40 monitor provides different configurations for Hemo measurement. The user can identify Hemo connectors’ configuration from connectors and label.

Hemo connectors’ type

Basic feature

Optional feature

Identifier

ECG

NIBP

SpO2

IBP

Temperature

(a) Hemo with GE SpO2

X

X

GE SpO2

X

X

2051591-001

(b) Hemo with Masimo SpO2

X

X

Masimo SpO2

X

X

2051591-001 2030041-001

(a) Hemo with Nellcor SpO2

X

X

Nellcor SpO2

X

X

2051591-001 2030043-001

(d) Hemo with GE SpO2, without X IBP

X

GE SpO2

X

2061934-001

(e) Hemo with Masimo SpO2, without IBP

X

X

Masimo SpO2

X

2061934-001 2030041-001

(f) Hemo with Nellcor SpO2, without IBP

X

X

Nellcor SpO2

X

2061934-001 2030043-001

(j) Hemo with GE SpO2, without IBP and Temp

X

X

GE SpO2

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2054075-001

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Command board keys 1

2a

3

Admit/ Discharge

4

5

Monitor Setup

Print/ Record

ECG

NIBP

Airway Gas

NIBP Auto Recorder On/Off Start/Stop

Take Snapshot

SpO2

IBP

Others

NIBP Start/ IBP Cancel Zero All

Pt.Data & Alarms Trends Setup

2b

14

13

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(1) ON/OFF key (2a) For battery status LEDs, refer to "Battery indicators" on page 23 for details (2b) For AC power status LED (3) For admitting or discharging a patient; for selecting user modes (4) For accessing the monitor settings and for activating the menu (5) For printing and recording different trends and waveforms (6) For activating parameter specific menus. (7) For starting or stopping the NIBP auto cycling (8) For starting or stopping local recording NOTE: Functional only when recorder option is available.

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(9) For silencing the alarms (10) For returning the normal screen view to the screen (11) For zeroing the invasive pressure channels NOTE: Functional only when IBP option is available. (12) For starting or stopping the NIBP manual determination. (13) For activating the Alarms Setup menu (14) For viewing trends and alarm history (15) For taking up to 10 snapshots

Symbols Type BF (IEC 60601-1) protection against electric shock. Isolated (floating) applied part suitable for intentional external and internal application to the patient, excluding direct cardiac application.

− On the rear panel: − Electric shock hazard. Do not open the cover

or the back. Refer servicing to qualified personnel. − For continued protection against fire hazard, replace the fuse only with one of the same type and rating. − Disconnect from the power supply before servicing. − Do not use the monitor without manufacturer approved mounting attached. − On the hemo module: Protection against cardiac defibrillator discharge is due in part to the accessories for pulse oximetry (SpO2), temperature (T) and invasive pressure (P) measurement.

Type BF (IEC 60601-1) defibrillator-proof protection against electric shock. Isolated (floating) applied part suitable for intentional external and internal application to the patient, excluding direct cardiac application. Type CF (IEC 60601-1) protection against electric shock. Isolated (floating) applied part suitable for intentional external and internal application to the patient, including direct cardiac application. Type CF (IEC 60601-1) defibrillator-proof protection against electric shock. Isolated (floating) applied part suitable for intentional external and internal application to the patient including direct cardiac application.

Follow instructions about operation.

Indicates that the audio off.

Refer to instruction manual/booklet about operation.

In the front panel: battery.

Electrostatic sensitive device. Connections should not be made to this device unless ESD precautionary procedures are followed.

Equipotentiality. Monitor can be connected to potential equalization conductor.

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16 Alternating current

European authorized representative.

Bell cancel. Audio pause.

European Union Declaration of Conformity.

Home. Return to the normal screen view. Rx Only U.S. ON/OFF.

Prescriptive Device. USA only. For use by or on the order of a Physician, or persons licensed by state law. Fragile. Handle with care.

Fuse. Replace the fuse only with one of the same type and rating

Keep dry. Protect from rain.

Gas inlet.

Gas outlet.

IP21 SN,S/N

Degree of ingress protection.

This way up.

Storage temperature

Serial number Date of manufacture. This symbol indicates the date of manufacture of this device. The four digits identify the year.

Humidity limitations.

Maunfacturer: This symbol indicates the name and the address of the manufacturer.

Atmospheric pressure limitations.

Recycled materials or may be recycled.

Battery (A) charging (white bar)

This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please, contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.

B

Both batteries failed

The separate collection symbol is affixed to a battery, or its packaging, to advise you that the battery must be recycled or disposed of in accordance with local or country laws. To minimize potential effects on the environment and human health, it is important that all marked batteries that you remove from the product are properly recycled or disposed. For information on how the battery may be safely removed from the device, please consult the service manual or equipment instructions. Information on the potential effects on the environment and human health of the substances used in batteries is available at this url: http://www.gehealthcare.com/euen/weeerecycling/index.html

A B

B

Battery (A) failure

Battery (A) missing Submenu. Selecting a menu item with this symbol opens a new menu. The monitor is connected to Network via LAN. A blinking heart next to the heart rate or pulse rate value indicates the beats detected. A lung next to the respiration rate value indicates that respiration rate is calculated from the impedance respiration measurement.

Battery operation and remaining capacity. The height of the green bar indicates the charging level.

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